{"product_name":"Sonio Detect","company_name":"Sonio","product_url":"https://sonio.ai/products/","company_url":"https://sonio.ai","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0224","summary":"Sonio Detect is an AI-powered software that assists ultrasound practitioners in real-time during fetal ultrasound examinations, enhancing quality and efficiency.","description":"Sonio Detect is an FDA 510(k) cleared AI software designed to support ultrasound practitioners by automatically detecting views, anatomical structures, and verifying quality criteria in real-time during fetal ultrasound exams. It integrates with various ultrasound machines and adapts to diverse patient demographics, including variations in BMI, maternal age, and ethnicity. The software has demonstrated high sensitivity and specificity across different patient subgroups. Additionally, Sonio Detect has been FDA cleared for analysis of prenatal ultrasound exams in August 2023. ([auntminnie.com](https://www.auntminnie.com/clinical-news/ultrasound/article/15633974/fda-clears-sonios-ai-for-prenatal-ultrasound-software?utm_source=openai))","categories":["clinical Care","diagnostic Support","patient Facing","Clinical","Diagnostic","Patient-facing"],"market_segment":["Enterprise","SMB"],"target_users":["Sonographers","OB/GYNs","Maternal-Fetal Medicine Specialists","Fetal Surgeons"],"specialties":["Obstetrics","Gynecology","Maternal-fetal Medicine"],"regions_available":["United States","France"],"languages_supported":["English","French"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["United States","France"],"company_founding":"2020","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Automatic detection and labeling of fetal ultrasound views","Identification of anatomical structures within ultrasound views","Verification of ultrasound image quality against standardized criteria","Real-time feedback on image quality during ultrasound exams","Automated sorting and management of ultrasound images and videos","Integration with existing ultrasound machines and clinical systems","Voice-controlled reporting assistant for hands-free documentation","Customizable reporting templates based on ultrasound findings","Clinical decision support features powered by AI algorithms","Automated population of report fields using AI and voice input","Visual checklist to track required ultrasound views during exams","Patient app for secure sharing of ultrasound images and reports","Practice analytics to monitor and improve clinical performance","Cloud-based technology for secure, remote access to ultrasound exams","Continuous software updates to incorporate latest imaging technology and AI advancements","Compliance with HIPAA privacy and security requirements","ISO 13485 certified quality management system","SOC 2 Type 2 compliance for data security","EU-GDPR compliance for data protection","Flexible deployment options including isolated multi-region deployments"],"optional_modules":["Sonio Voice","Sonio Suspect"],"integrations":["Ultrasound machines","EHR systems","PACS/VNA","Billing systems","eFAX support","IMO","LOINC","DICOM worklist","HL7 (ADT, SIU, ORU, ORM, etc.)","FHIR","Custom integrations"],"data_standards":["FHIR","HL7 v2","DICOM","SNOMED","ICD-10"],"api_available":"yes","system_requirements":"Major OS/DB/hardware needs, or empty if SaaS-only","compliance":["HIPAA","GDPR","HITECH","SOC 2","ISO 27001"],"certifications":["FDA 510(k)","CE/MDR","ONC","ISO 13485"],"security_features":["Encryption","RBAC","SSO/SAML","audit logs","2FA","DLP"],"privacy_features":["BAA available","consent mgmt","anonymization","data minimization"],"data_residency":"EU-only, US/EU regions, BYO cloud region","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0224","slug":"sonio-detect","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/sonio-detect.json"}}